MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during cataract surgery with intraocular lens implantation, a preloaded delivery system inserter got hung up.Patient contact was reported.The procedure was completed the same day.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned inside the opened blister tray, loose in a biohazard bag.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed dried in the device.The plunger has advanced the lens to mid-nozzle.The plunger is engaging the optic edge.The leading haptic is extended.The trailing haptic is folded onto the optic.The plunger and lens were in acceptable positions.It is possible that the lens became stuck in dried viscoelastic, contributing to the perceived complaint.The nozzle was cleaned for further evaluation.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported issue.The lens was advanced to mid-nozzle and dried in viscoelastic.The position of the haptics, optic, and plunger are acceptable.The plunger is engaging the optic edge correctly.The plunger and lens were in acceptable positions.It is possible that the lens became stuck in dried viscoelastic, contributing to the perceived complaint.A straight leading haptic position was observed.Straight leading haptics are not a product malfunction.Straight leading haptics are an acceptable position per the diagrams provided in the dfu.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10401188
• MDR Text Key: 203514632
• Report Number: 1119421-2020-01131
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12760756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1